- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008563
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (B-FiERCE)
Study Overview
Status
Intervention / Treatment
Detailed Description
The incidence of endometrial cancer is increasing at an alarming rate (2.6% per year). This trend parallels the rising rate of obesity, the most significant increasing risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility and thus avoid hysterectomy are treated with progestin therapy, such as progestin intra-uterine device (pIUD). However, the pIUD achieves cancer regression in only 50-70% of women, and over 50% of initial responders will develop recurrence within two years. The effectiveness of the pIUD may be improved if the driver of endometrial cancer (obesity) was simultaneously addressed. Multiple epidemiologic studies have demonstrated that bariatric surgery reduces the risk of developing endometrial cancer. Our research aims to answer the question: "Is bariatric surgery in addition to the pIUD a feasible and acceptable option for young women with endometrial cancer/atypical hyperplasia who wish to maintain their childbearing potential compared to standard treatment of pIUD alone?
This is a pilot randomized controlled trial to assess the feasibility of a full-scale randomized controlled trial. Eligible women will be identified and consented over a 21-month period, and participants will be randomized to bariatric surgery plus standard pIUD (intervention group) or to standard pIUD alone (non-intervention group) in a 1:1 fashion.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tara Zad
- Phone Number: 3165 416-946-4501
- Email: Tara.Zad@uhn.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- Recruiting
- Princess Margaret Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- BMI ≥ 35
- Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
- Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by physical exam or imaging performed (MRI, CT)
- ECOG status <2
- Desire for fertility preservation
- No contraindications to progestin intrauterine device (IUD)
- Have signed an approved informed consent form
Exclusion Criteria:
- Evidence of myometrial invasion or extra-uterine disease on imaging
- High grade or p53 endometrial cancer
- History of other malignancies, except if curatively treated with no evidence of disease for > 5 years
- Evidence of adenomyosis seen on MRI
- Previous major upper abdominal surgery (ex. splenectomy, partial gastrectomy, liver resection, bowel resection). *Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion
- Current use of weight loss medication
- Contraindications to sleeve gastrectomy
- Medical co-morbidity with end-organ dysfunction
- Unable to understand and participate in the informed consent process
- Currently pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bariatric Surgery and Progestin Intrauterine Device
This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
|
Patients who are randomized to the intervention group will receive a progestin intrauterine device and be referred for bariatric service to undergo bariatric surgery within 3 months of their study consent.
|
No Intervention: Progestin Intrauterine Device Alone
This group will receive a progestin intrauterine device alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment Rate
Time Frame: Year 3
|
To determine the proportion of eligible women who agree to participate in the study (recruitment rate).
The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥ 40% recruitment rate is achieved.
Patients' reasons for participation or non-participation will be recorded.
|
Year 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of Bariatric Surgery
Time Frame: Year 3
|
Proportion of patients who complete bariatric surgery within 3 months of randomization.
A rate of >85% will be considered feasible.
|
Year 3
|
Loss to Follow-Up Rate
Time Frame: Year 3
|
Loss to follow-up rate, defined as proportion of patients who do not complete 15-month assessment.
A loss to follow-up rate of <20% will be considered feasible.
|
Year 3
|
Completion of Patient Reported Outcome Questionnaires
Time Frame: Year 3
|
Completion rate of patient reported outcomes that will be used in the full-scale randomized controlled trial.
Completion of >80% of patient reported outcomes at baseline will indicate that use of these questionnaires is feasible.
|
Year 3
|
Complete Response Rate
Time Frame: Year 3
|
Overall complete response rate (CRR) after treatment with progestin intrauterine device (pIUD).
This study is not powered to detect an improvement in CRR in the intervention vs. non-intervention group.
However, the proportion of women who obtain a complete response in the pIUD alone group at 15 months will be used as the baseline CRR for this population and will be used to derive a sample size for a full-scale randomized controlled trial.
We believe that this will be more accurate than using published data retrospective studies that are not specific to women with obesity.
We will also collect the following data: (a) time to complete response, (b) overall recurrence rate, and (c) time to recurrence.
|
Year 3
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah E Ferguson, MD, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Hyperplasia
- Endometrial Neoplasms
Other Study ID Numbers
- 19-5487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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